Literature

Some of the literature identified during the study of 510(k) process

[No_authors_listed]. Medical devices; substantial equivalence; 510(K) summaries and 510(K) statements; class III summaries; confidentiality of information--FDA. Final rule. Fed Regist. 1994;59(239):64287-96.

Altenstetter C. EU and member state medical devices regulation. International journal of technology assessment in health care. 2003;19(1):228-48.

Asamoah AK, Sharfstein JM. Transparency at the Food and Drug Administration. N Engl J Med. 2010;362(25):2341-3.

Buchman AL, Spapperi J, Francuzenko KW, Blakeslee MR, Toffenetti J, Leopold P. Medical device development: design, engineering, testing, and legal issues protection-steps in the process to success. Am J Gastroenterol. 2009;104(3):543-5.

Cookson R, Hutton J. Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective. Health Policy. 2003;63(2):167-78.

Donawa M. Addressing US and European device testing requirements. Medical device technology. 2008;19(5):32, 4-7.

Donawa M. European medical device regulation: a new era? Medical device technology. 2004;15(10):30-1.

Donawa M. US guidance on formatting 510(k)s. Med Device Technol. 2006;17(2):27-9.

Donawa M. US regulation of combination products. Med Device Technol. 2009;20(6):22, 4-5.

Donawa ME. Who owns the 510(k)? Med Device Technol. 2008;19(2):26, 8-9.

Feldman MD, Petersen AJ, Karliner LS, Tice JA. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J Gen Intern Med. 2008;23 Suppl 1:57-63..

Fielder J. Ethics and the FDA. IEEE Eng Med Biol Mag. 2006;25(4):13-7.

Flaherty JM, Jr. Defending substantial equivalence: an argument for the continuing validity of the 510(k) premarket notification process. Food Drug Law J. 2008;63(4):901-27.

Gagliardi J. Guidelines for planning and hosting a successful FDA medical device inspection. Biomed Instrum Technol. 2009;43(6):472-5.

Garber AM. Modernizing device regulation. N Engl J Med. 2010;362(13):1161-3.

Goldberger BA. The evolution of substantial equivalence in FDA's premarket review of medical devices. Food Drug Law J. 2001;56(3):317-37.

Hall RF, Stensvad E. A Failure to Comply: An Initial Assessment of Gaps in IOM’s Medical Device Study Committee. Minn. J.L. Sci. & Tech. 2011;12(2):E1-E18.

Hines JZ, Lurie P, Yu E, Wolfe S. Left to their own devices: breakdowns in United States medical device premarket review. PLoS Med. 2010;7(7):e1000280. .

Hirsch L. Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors. Curr Med Res Opin. 2008;24(6):1683-9.

Hogan J, Simmons G. Standards for Clearance of 510(k) Premarket Notifications in the US. Regulatory Affairs Journal - Devices. 2008;Sept/Oct 2008:311-7.

Jefferys DB. The regulation of medical devices and the role of the Medical Devices Agency. Br J Clin Pharmacol. 2001;52(3):229-35

Kohler A. A 510(k) Primer: FDA's Premarket Notification Process. MDDI Magazine [serial on the Internet]. 1996: Available from: http://www.mddionline.com/article/510k-primer-fdas-premarket-notification-process.

Kretzer RM, Foreman CL, Shuren J. Modernizing device regulation. N Engl J Med. 2010;363(2):196-7; author reply 7.

Lanzafame RJ. Responsibilities and innovation. Photomed Laser Surg. 2010;28(1):1-2.

Lenzer J. Watching over the medical device industry. BMJ. 2009;338:b2321.

Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ. 2010;341:c4753.

Link DM. Cooper Committee Report and Its Effect on Current FDA Medical Device Activities. Food Drug Cosmetic Law Journal. 1972;27:624-8.

Maisel WH. Medical device regulation: an introduction for the practicing physician. Ann Intern Med. 2004;140(4):296-302.

Mansfield E, O'Leary TJ, Gutman SI. Food and Drug Administration regulation of in vitro diagnostic devices. J Mol Diagn. 2005;7(1):2-7.

McGivney WT, Hendee WR. Regulation, coverage, and reimbursement of medical technologies. Int J Radiat Oncol Biol Phys. 1990;18(3):697-700.

Mills AG, D'Emanuele R. Protecting yourself from your assertions: navigating multiple regulatory schemes and disclosure. J Health Life Sci Law. 2009;2(2):109, 11-23.

Moore J. University of Minnesota Professor: Tests on humans won't ensure device safety: A study of FDA product recalls shows that more clinical testing wouldn't prevent most problems. Star Tribune. 2010 August 11, 2010;Sect. 1.

O'Connor AB. Building comparative efficacy and tolerability into the FDA approval process. JAMA. 2010;303(10):979-80.

Patsner B. Riegel v. Medtronic, Inc.: revisiting pre-emption for medical devices. J Law Med Ethics. 2009;37(2):305-17.

Pietzsch JB, Zanchi MG, Linehan JH. Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy. J. Med. Devices 7(2), June 24, 2013

Samp RA. Modernizing device regulation. N Engl J Med. 2010;363(2):196; author reply 7.

Shapiro J.K. (Director, Hyman, Phelps & McNamara) Substantial Equivalence Review of Medical Devices, 2013 (Video, White paper and Slides)

Steg H, Thumm N. Single-market regulation and innovation in Europe's medical devices industry. International journal of technology assessment in health care. 2001;17(3):421-32.

Stensvad E, Hall RF. Left to Their Own Devices: IOM’s Medical Device Committee’s Failure to Comply. Minn J.L. Sci & Tech, 2011 Vol 13(1). Submitted draft

Tolomeo DE. The use of Food and Drug Administration 510(k) notifications in patent litigation. Food Drug Law J. 2004;59(4):465-77.

VanBuren M. Closing the loopholes in the regulation of medical devices: the need for Congress to reevaluate medical device regulation. Health Matrix Clevel. 2007;17(2):441-65.